The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Hoffman-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures. |
| Health Canada Endorsed Important Safety Information on
Lariam® (mefloquine) |
January 24, 2005
| Subject: |
Lariam® (mefloquine) - Updated Patient Information |
Dear Health Care Professional,
Hoffmann-La Roche Limited, following discussions with Health Canada, would
like to inform you of the availability of an updated Patient Information pamphlet for Lariam® (mefloquine) that applies to patients taking Lariam® (mefloquine) as a prophylactic antimalarial drug. A copy is attached.
The updated Patient Information pamphlet:
- is intended to help patients recognize symptoms, including the sudden onset of unexplained anxiety, depression, restlessness, irritability, confusion, a persistently abnormal heart beat, or palpitations, that may precede rare but potentially serious psychiatric, neurologic, or cardiac adverse events;
- advises patients who develop these symptoms to contact a Health Care Professional to assess the need for discontinuation of Lariam® (mefloquine) treatment; and
- includes a wallet card containing a summary of the most essential information, that may be cut out and carried by the patient during travel to areas with malaria.
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The Patient Information pamphlet is provided in every box of Lariam® (mefloquine). As stated in the text printed on every box, Pharmacists are asked to provide patients with the Patient Information document with each prescription or refill dispensed and to direct patients to the wallet card at the end of the document.
Please display the enclosed Public Advisory in your waiting room to inform your patients of the existence of this new Patient Information pamphlet.
Your professional commitment to the informed use of Lariam® (mefloquine) represents an important contribution to the protection of patients' well-being through the early recognition of potentially serious adverse events by patients.
The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of neurologic, psychiatric, or cardiac adverse events, or other serious and/or unexpected adverse events in patients receiving Lariam® (mefloquine), should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:
Hoffmann-La Roche Limited
Drug Information and Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at 1-888-762-4388
or fax at 905-542-5610
or email to: Mississauga.canada_medinfo@roche.com
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel.: (613) 954-6522
Fax: (613) 952-7738
The AR Reporting Form and the AR
Guidelines can be found on the Health Canada web site or in The
Canadian Compendium of Pharmaceuticals and Specialties. |
Should you have any questions or require additional information regarding the use of Lariam® (mefloquine) please contact the Drug Information and Safety Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.
Sincerely,
original signed by
Lorenzo Biondi
Vice President, Medical and Regulatory Affairs
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